Cleared Traditional

K092028 - PHILIPS AVALON FETAL MONITORS FM20, FM30, FM40, AND FM50

K092028 is an FDA 510(k) clearance for PHILIPS AVALON FETAL MONITORS FM20, manufactured by Philips Medizin Systeme Boeblingen GmbH. The device is a Class 2 Obstetrics & Gynecology device with product code HGM cleared through the Traditional 510(k) pathway after a 226-day FDA review.

K092028 · Philips Medizin Systeme Boeblingen GmbH · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2010
Decision
226d
Days
Class 2
Risk

K092028 is an FDA 510(k) clearance for the PHILIPS AVALON FETAL MONITORS FM20, FM30, FM40, AND FM50. Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Philips Medizin Systeme Boeblingen GmbH (Boeblingen, Bw, DE). The FDA issued a Cleared decision on February 17, 2010 after a review of 226 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.2740 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K092028

510(k) Number K092028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2009
Decision Date February 17, 2010
Days to Decision 226 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d slower than avg
Panel avg: 161d · This submission: 226d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HGM Device Classification - Class 2, Special Controls

Product Code HGM System, Monitoring, Perinatal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.2740
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HGM System, Monitoring, Perinatal

All 214
Devices cleared under the same product code (HGM) and FDA review panel - the closest regulatory comparables to K092028.
FETAL MATERNAL MONITOR MODEL F9 EXPRESS AND EXPRESS
K100797 · Edan Instruments, Inc. · Nov 2010
PHILIPS OBTRACEVUE MODEL SW REV. G.00
K100420 · Philips Medizin Systeme Boeblingen GmbH · Jul 2010
FETAL MONITOR MODEL: BT-200T
K100885 · Bistos Co., Ltd. · Jun 2010
CERNER FETALINK (VERSION 1.0)
K091251 · Cerner Corp. · Aug 2009
SONICAID FM820 AND FM830 ENCORE
K090285 · Huntleigh Healthcare , Ltd. · Jul 2009
AIRSTRIP OB
K090269 · Airstrip Technologies, LP · Feb 2009
K092028 · PHILIPS AVALON FETAL MONITORS FM20, FM30, FM40, AND FM50
Download PDF FDA Summary Philips Medizin Syste…